Reducing Anxiety and Dyspnea via Device-Guided Breathing (RELAX): A Multi-Site Feasibility Study in Post-Treatment Lung Cancer Survivors at Community Cancer Clinics (WF-01213).

INTRODUCTION: Anxiety and dyspnea are 2 common symptoms for lung cancer survivors. Although research suggests decreasing respiration rate can reduce anxiety in several populations, potential benefits of device-guided breathing have not been studied in lung cancer survivors. This feasibility study (WF-01213) provides estimates of accrual, adherence, retention, and preliminary efficacy of 2 doses of a device-guided breathing intervention versus a usual breathing control group for improving self-reported anxiety and dyspnea in post-treatment lung cancer survivors. METHODS: Stage I-IV lung cancer survivors were recruited through the NCI Community Oncology Research Program (NCORP) and randomized to 12 weeks of a device-guided breathing intervention (high dose vs. low dose) or control device. Self-reported outcomes (anxiety, depression, dyspnea, cancer-related worry, fatigue) were assessed at baseline, mid-intervention (Week-6), and post-intervention (Week-12). RESULTS: Forty-six participants (ages 41-77, median = 65; 78% White) were randomized to the high-dose intervention (n = 14), low-dose intervention (n = 14), or control (n = 18) groups between July 2015 and September 2019. Study accrual rate was 0.92 per month for 50 months (projected accrual was 6.3/month). Fourteen participants (30%) withdrew early from the study, with almost half of those discontinuing at or immediately following baseline assessment. No participants were adherent with the intervention per protocol specifications. The proportion minimally adherent (using device at least 1x/week) was 43% (6/14), 64% (9/14), and 61% (11/18) for high-dose, low-dose, and control groups, respectively. Anxiety significantly decreased from baseline for all groups at Week 12. Adherence to the intervention was low across all treatment groups. CONCLUSIONS: This study did not establish feasibility of a community-based randomized trial of 2 doses of device-guided breathing and a control group using an identical-looking device for lung cancer survivors. In both the high-dose and control groups, there were significant improvements from baseline for anxiety and dyspnea. In the low-dose group, there were significant improvements from baseline for anxiety and depression. Ratings and feedback on the intervention were mixed (although leaned in a positive direction). Participants reported liking the feeling of relaxation/calm, helping others, breathing awareness, and music. Participants reporting liking least finding/making time to use the device, frustration with the device, and completing study forms. TRIAL REGISTRATION: CLINICAL TRIALS ID: NCT02063828, clinicaltrials.gov.

A Randomized Preference Trial Comparing Cognitive-Behavioral Therapy and Yoga for the Treatment of Late-Life Worry: Examination of Impact on Depression, Generalized Anxiety, Fatigue, Pain, Social Participation, and Physical Function.

Background: Depression, generalized anxiety, fatigue, diminished physical function, reduced social participation, and pain are common for many older adults and negatively impact quality of life. The purpose of the overall trial was to compare the effects of cognitive-behavioral therapy (CBT) and yoga on late-life worry, anxiety, and sleep; and examine preference and selection effects on these outcomes. Objective: The present analyses compared effects of the 2 interventions on additional outcomes (depressive symptoms, generalized anxiety symptoms, fatigue, pain interference/intensity, physical function, social participation); and examined whether there are preference and selection effects for these treatments. Methods: A randomized preference trial of CBT and yoga was conducted in adults ≥60 years who scored ≥26 on the Penn State Worry Questionnaire-Abbreviated (PSWQ-A), recruited from outpatient medical clinics, mailings, and advertisements. Cognitive-behavioral therapy consisted of 10 weekly telephone sessions. Yoga consisted of 20 bi-weekly group yoga classes. Participants were randomized to(1): a randomized controlled trial (RCT) of CBT or yoga (n = 250); or (2) a preference trial in which they selected their treatment (CBT or yoga; n = 250). Outcomes were measured at baseline and post-intervention. Results: Within the RCT, there were significant between-group differences for both pain interference and intensity. The pain interference score improved more for the CBT group compared with the yoga group [intervention effect of (mean (95% CI) = 2.5 (.5, 4.6), P = .02]. For the pain intensity score, the intervention effect also favored CBT over yoga [.7 (.2, 1.3), P < .01]. Depressive symptoms, generalized anxiety, and fatigue showed clinically meaningful within-group changes in both groups. There were no changes in or difference between physical function or social participation for either group. No preference or selection effects were found. Conclusion: Both CBT and yoga may be useful for older adults for improving psychological symptoms and fatigue. Cognitive-behavioral therapy may offer even greater benefit than yoga for decreasing pain.

Long-Term Effects of Cognitive-Behavioral Therapy and Yoga for Worried Older Adults.

OBJECTIVES: Cognitive-behavioral therapy (CBT) and yoga decrease worry and anxiety. There are no long-term data comparing CBT and yoga for worry, anxiety, and sleep in older adults. The impact of preference and selection on these outcomes is unknown. In this secondary data analysis, we compared long-term effects of CBT by telephone and yoga on worry, anxiety, sleep, depressive symptoms, fatigue, physical function, social participation, and pain; and examined preference and selection effects. DESIGN: In this randomized preference trial, participants (N = 500) were randomized to a: 1) randomized controlled trial (RCT) of CBT or yoga (n = 250); or 2) preference trial (selected CBT or yoga; n = 250). Outcomes were measured at baseline and Week 37. SETTING: Community. PARTICIPANTS: Community-dwelling older adults (age 60+ years). INTERVENTIONS: CBT (by telephone) and yoga (in-person group classes). MEASUREMENTS: Penn State Worry Questionnaire - Abbreviated (worry);1,2 Insomnia Severity Index (sleep);3 PROMIS Anxiety Short Form v1.0 (anxiety);4,5 Generalized Anxiety Disorder Screener (generalized anxiety);6,7 and PROMIS-29 (depression, fatigue, physical function, social participation, pain).8,9 RESULTS: Six months after intervention completion, CBT and yoga RCT participants reported sustained improvements from baseline in worry, anxiety, sleep, depressive symptoms, fatigue, and social participation (no significant between-group differences). Using data combined from the randomized and preference trials, there were no significant preference or selection effects. Long-term intervention effects were observed at clinically meaningful levels for most of the study outcomes. CONCLUSIONS: CBT and yoga both demonstrated maintained improvements from baseline on multiple outcomes six months after intervention completion in a large sample of older adults. TRIAL REGISTRATION: www. CLINICALTRIALS: gov Identifier NCT02968238.

Predictors of preference for cognitive-behavioral therapy (CBT) and yoga interventions among older adults.

The purpose of this study was to examine factors that influence a person's choice of cognitive-behavioral therapy (CBT) or yoga, the stability of these preferences, and the impact of preference on engagement and process measures. We conducted a randomized preference trial of CBT and yoga in 500 adults ≥60 years with symptoms of worry. Participants reported their intervention preference, strength of preference, and factors impacting preference. Engagement in the intervention (session completion and dropout rates) was assessed. Process measures included satisfaction with the intervention, therapeutic alliance, and intervention expectancy. Neither intervention preference (48% and 52% chose CBT and yoga, respectively) nor strength of preference differed significantly between the two preference trial groups. Intervention expectancies at baseline among those in the preference trial were approximately 4.5 units (40-point scale) higher for their preferred intervention (p < .0001 within each group). A principal component analysis of factors influencing preference identified three constructs. Using logistic regression, components focused on attitudes about CBT or yoga were predictive of ultimate preference (odds ratio = 11.5, 95% C.I.6.3-21.0 per 1SD difference in component 1 for choosing CBT; odds ratio = 7.8, 95% CI4.3-13.9 per 1SD difference in component 2 for choosing yoga). There were no significant differences between the randomized and preference trials on intervention adherence, completion of assessments, intervention satisfaction, or working alliance. Receiving a preferred treatment had no significant effects on intervention outcomes through participant engagement or process measures. When options are limited, providers may have confidence in offering the most readily available non-pharmacological treatments.

Ensuring Yoga Intervention Fidelity in a Randomized Preference Trial for the Treatment of Worry in Older Adults.

Introduction: Yoga for treatment of worry in older adults is an intervention that is especially likely to translate into real-world practice. Assessing treatment fidelity improves confidence that effective interventions can be consistently applied and allows researchers to explore if any null results for effectiveness are indeed the result of a lack of intervention efficacy or lack of proper intervention implementation. Methods: This study describes treatment fidelity of a yoga intervention in a randomized preference trial that compared cognitive-behavioral therapy (CBT) and yoga for the treatment of worry, anxiety, and sleep in worried older (≥60 years) adults. Established methods for assessing treatment fidelity of CBT guided the procedure for ensuring that the yoga intervention was delivered as intended. The yoga intervention consisted of 20, 75-min, in-person, group, gentle yoga classes held twice weekly. Results: Six female instructors (mean age = 64 years) taught 660 yoga classes that were videotaped. Ten percent of these classes, stratified by instructor, were randomly selected for review. The average adherence score for yoga instructors was 6.84 (range 4-8). The average competency scores were consistently high, with an average score of 7.24 (range 6-8). Teaching content not included in the protocol occurred in 26 (38.1%) sessions and decreased over time. Observed ratings of instructor adherence were significantly related to ratings of competency. Instructor adherence was also significantly associated with lower participant attendance, but not with any of the other process or outcome measures. Conclusions: The larger range found in adherence relative to competence scores demonstrated that teaching a yoga class according to a protocol requires different skills than competently teaching a yoga class in the community, and these skills improved with feedback. These results may foster dialog between the yoga research and practice communities. Clinical Trial Registration No.: NCT02968238.

Corrigendum to 'A randomized preference trial of cognitive-behavioral therapy and yoga for the treatment of worry in anxious older adults' [Contemp. Clin. Trials Commun. 10 (2018) 169-176].

[This corrects the article DOI: 10.1016/j.conctc.2018.05.002.].

Comparison of cognitive-behavioral therapy and yoga for the treatment of late-life worry: A randomized preference trial.

BACKGROUND: The purpose of this study was to compare the effects of cognitive-behavioral therapy (CBT) and yoga on late-life worry, anxiety, and sleep; and examine preference and selection effects on these outcomes. METHODS: A randomized preference trial of CBT and yoga was conducted in community-dwelling adults 60 years or older, who scored 26 or above on the Penn State Worry Questionnaire-Abbreviated (PSWQ-A). CBT consisted of 10 weekly telephone sessions. Yoga consisted of 20 biweekly group yoga classes. The primary outcome was worry (PSWQ-A); the secondary outcomes were anxiety (PROMIS-Anxiety) and sleep (Insomnia Severity Index [ISI]). We examined both preference effects (average effect for those who received their preferred intervention [regardless of whether it was CBT or yoga] minus the average for those who did not receive their preferred intervention [regardless of the intervention]) and selection effect (which addresses the question of whether there is a benefit to getting to select one intervention over the other, and measures the effect on outcomes of self-selection to a specific intervention). RESULTS: Five hundred older adults were randomized to the randomized trial (125 each in CBT and yoga) or the preference trial (120 chose CBT; 130 chose yoga). In the randomized trial, the intervention effect of yoga compared with CBT adjusted for baseline psychotropic medication use, gender, and race was 1.6 (-0.2, 3.3), p = .08 for the PSWQ-A. Similar results were observed with PROMIS-Anxiety (adjusted intervention effect: 0.3 [-1.5, 2.2], p = .71). Participants randomized to CBT experienced a greater reduction in the ISI compared with yoga (adjusted intervention effect: 2.4 [1.2, 3.7], p < .01]). Estimated in the combined data set (N = 500), the preference and selection effects were not significant for the PSWQ-A, PROMIS-Anxiety, and ISI. Of the 52 adverse events, only two were possibly related to the intervention. None of the 26 serious adverse events were related to the study interventions. CONCLUSIONS: CBT and yoga were both effective at reducing late-life worry and anxiety. However, a greater impact was seen for CBT compared with yoga for improving sleep. Neither preference nor selection effects was found.

The Effects of Yoga on Patients with Mild Cognitive Impairment and Dementia: A Scoping Review.

Yoga is an ancient mind body practice. Although yoga has been used as a complementary health approach for enhancing wellness and addressing a variety of health issues, little is known about the impact of yoga on cognitive functioning in adults with mild cognitive impairment (MCI) and dementia. We conducted a literature review to examine the impact of yoga on persons with MCI and dementia. Eight studies were identified that reported on yoga as either the primary intervention or one component of a multi-component intervention in samples of persons with MCI or dementia. Results suggest that yoga may have beneficial effects on cognitive functioning, particularly on attention and verbal memory. Further, yoga may affect cognitive functioning through improved sleep, mood, and neural connectivity. There are a number of limitations of the existing studies, including a lack of intervention details, as well as variability in the frequency/duration and components of the yoga interventions. A further complicating issue is the role of various underlying etiologies of cognitive impairment. Despite these limitations, providers may consider recommending yoga to persons with MCI or dementia as a safe and potentially beneficial complementary health approach.

A randomized preference trial of cognitive-behavioral therapy and yoga for the treatment of worry in anxious older adults.

BACKGROUND: Worry is a common problem among older adults. Cognitive-behavioral therapy is the most studied nonpharmacological intervention and it has demonstrated efficacy in reducing late-life worry and anxiety. Although the evidence-base is smaller, yoga has been shown to reduce anxiety and stress. However, little is known about the relative effectiveness of these two nonpharmacological interventions. Further, the impact of patient preference on outcomes is unknown.Purpose: The purpose to this study is to compare the effectiveness of cognitive-behavioral therapy (CBT) with yoga for improving late-life worry, anxiety, and sleep. We will also examine the effects of preference and selection on outcomes, adherence, and attrition. METHODS: We are conducting a two-stage randomized preference trial comparing CBT and yoga for the reduction of worry in a sample of anxious older adults. Five hundred participants will be randomized to either the preference trial (participants choose the intervention; N = 250) or to the randomized trial (participants are randomized to one of the two interventions; N = 250) with equal probability. CBT consists of 10 telephone-based sessions with an accompanying workbook. Yoga consists of 10 weeks of group yoga classes (twice a week) that is modified for use with older adults. CONCLUSIONS: The study design is based on feedback from anxious older adults who wanted more nonpharmacological options for intervention as well as more input into the intervention they receive. It is the first head-to-head comparison of CBT and yoga for reducing late-life worry and anxiety. It will also provide information about how intervention preference affects outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02968238.